Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

July 31, 2006

Study Completion Date

July 31, 2006

Conditions
DiabetesDiabetes Mellitus, Type 2
Interventions
DRUG

repaglinide

Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order

DRUG

metformin

Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order

DRUG

repaglinide and metformin combination tablet

Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order

Trial Locations (2)

33169

Novo Nordisk Investigational Site, Miami

98418

Novo Nordisk Investigational Site, Tacoma

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY